A method known as a blow-fill-seal method (BFS method) is known in which receptacles, for example bottles made of extruded PE or PP, are blown in a sterile and pyrogen-free state into a desired shape in one operation and, directly after cooling, are filled aseptically with a sterile filler and hermetically sealed. The receptacles, in particular bottles, produced by the blow-fill-seal method are also referred to as BFS receptacles.
If the known BFS receptacles are used to receive sterile medical liquids, for example infusion solutions, the receptacles require a closure cap that allows the infusion solution to be transferred to the patient by means of an infusion appliance. The addition of medicaments to the infusion solution should likewise be possible.
WO 2008/095665 A1 discloses a closure cap for a receptacle for receiving medical liquids, in particular a BFS bottle. The known closure cap has a lid part and an edge part, with an injection part arranged in the lid part. The injection part has an outwardly directed connector part, with a conical recess that sealingly receives the conical stem of a needleless injection syringe, and an inwardly directed closure part, in which a self-sealing membrane is fitted. In addition to the injection part, the closure cap also has a withdrawal part for withdrawing a medical liquid using a spike.
A closure cap, which has a withdrawal part for withdrawing liquid and also an injection part for injecting an additive, is known from WO 2006/042579 A1.
The closure caps known from WO 2008/095665 A1 and from WO 2006/042579 A1 are characterized in that both closure caps have only one withdrawal part and one injection part. Both closure caps have proven effective in practice. The injection part permits subsequent injection of an additive or the injection of several additives in succession into the medical liquid. The injection part is closed in a sterile manner by a break-off part. A disadvantage is that, although the receptacle is still tightly sealed by the self-sealing membrane after the break-off part of the injection part has been broken off, the connector part of the injection part is exposed to a non-sterile environment. Therefore, there is in principle a danger of contamination of the injection part unprotected on the outside, and this proves disadvantageous if a further additive is to be injected at the injection part.
Closure caps for receptacles containing solutions for enteral nutrition are also known from U.S. Pat. No. 5,125,522 and U.S. Pat. No. 4,951,845. These closure caps only have one withdrawal site. In addition to the withdrawal site, the known closure caps have a vent opening, which is closed with a sterile filter.
WO 2006/115969 A3 describes a closure cap designed for a receptacle and having a large number of openings of different designs, for example round or star-shaped openings. All of the openings are distributed peripherally about the center of the closure cap.
Conical connectors with a conical stem and a conical sleeve whose conical surfaces are standardized are known in medical technology for connecting medical appliances. The unlockable cone connections with standardized cone surfaces are known as Luer connectors, and the lockable cone connections are known as Luer lock connectors. Luer syringes without screw connections and Luer lock syringes with screw connections are thus also known.
It is an object of the invention to make available a closure cap for receptacles for receiving medical liquids, in particular for receptacles filled with infusion or transfusion solutions or liquids for enteral nutrition, which closure cap is particularly easy to handle and can be used universally. It is also an object of the invention to make available a receptacle for receiving medical liquids, in particular a bottle, which is easy to handle and can be used universally.
According to the invention, these objects are achieved by the features specified in claims 1 and 17. Preferred embodiments of the invention are set forth in the dependent claims.
The closure cap according to the invention is characterized by two injection parts arranged separately from each other and each designed for injection of an additive. One injection part is used for injection of an additive using a needleless syringe, while the other injection part is used for injection of an additive using an injection syringe that has a needle. It is therefore possible to inject different additives into the medical liquid contained in the receptacle using a needleless injection syringe and also using an injection syringe with needle. The closure cap according to the invention can thus be used universally.
If, for example, a first additive has been injected via the first injection part, a second additive can be injected via the second injection part. Both injection parts are preferably closed tightly with a break-off part. If the break-off part of one injection part is broken off, the other injection part remains protected by the break-off part that has not been broken off. This has the advantage that the as yet unused injection part cannot be contaminated.
In a preferred embodiment, the closure cap has a lid part and an edge part, wherein the lid part has an inner portion and an outer portion which protrudes outward from the inner portion. The first and second injection parts and the withdrawal part are preferably arranged on the outer outwardly protruding portion of the lid part. Thus, the injection site and the withdrawal site extend forward such that the injection sites and the withdrawal site on the closure cap are easily accessible.
In a preferred embodiment, the first and second injection parts and the withdrawal part are arranged preferably lying next to one another in a row on the outer portion of the lid part. The outer portion of the lid part should extend as far as possible across the entire width of the lid part. In this way, sufficient space is made available for the arrangement of the injection parts and of the withdrawal part.
In an alternative embodiment, the injection parts and the withdrawal part are arranged offset in relation to one another on the outer portion of the lid part. In this alternative embodiment, the outwardly protruding portion of the lid part preferably has a substantially rectangular shape, such that sufficient space is made available for the injection parts and the withdrawal part.
The break-off parts for closing the injection parts and the withdrawal part preferably have lateral grip tabs, which preferably extend across the outer portion of the lid part. In this way, the grip tabs can be easily gripped from the side.
The injection part for the needleless injection syringe has an outwardly directed connector part, with a recess for receiving the conical stem of the syringe, and an inwardly directed closure part, in which a self-sealing membrane is arranged. The outwardly directed connector part of the first injection part preferably has an outer thread, such that a known Luer lock syringe can be attached to the connector part. However, it is also possible that the connector part of the injection part has no outer thread, such that only the attachment of a known Luer syringe is possible.
In one embodiment a hollow body with a point is arranged in the recess of the connector part of the injection part which is designed for injecting an additive into the medical liquid using a needleless injection syringe, wherein the membrane and the hollow body are arranged in the recess of the connecting part in such a manner that the membrane is pierced when the syringe is connected to the connecting part, wherein the membrane is arranged above the hollow body in the recess of the connecting part and therefore, when the syringe is connected to the connecting part, the membrane is pressed by the syringe onto the point of the hollow body. In one embodiment the hollow body is designed as a cannula with a ground section. In a further embodiment the hollow body in the recess of the connecting part is fastened to a disk-shaped body which preferably has openings, preferably for ventilation purposes. These openings in the disk-shaped body are for instance bores which can be distributed circumferentially around the hollow body.
The receptacle according to the invention, in particular an infusion or transfusion receptacle or a receptacle for receiving a solution for enteral nutrition, is preferably designed as a bottle, in particular an SBM (stretch-blow-molding) bottle that is closed with the closure cap according to the invention.
According to one embodiment the closure cap comprises or consists of polypropylene and/or polyethylene. In one further embodiment the membrane comprises or consists of polyisoprene and/or brominebutyl and/or chlorinebutyl.
According to one embodiment the withdrawal part for withdrawing the medical liquid using a spike is adapted to receive a spike having a diameter in the range of approximately at least 5 mm to approximately 6.5 mm. In another embodiment the injection part for injecting an additive into the medical liquid using a needleless injection syringe is adapted to receive a Luer-Lock syringe having a cone diameter of about 4 mm. In one further embodiment the second injection part designed for injecting an additive into the medical liquid using an injection syringe that has a needle is adapted to receive a needle having a diameter up to about 5 mm. For instance the outer diameter of the closure cap is in the range of 30 mm to 40 mm. For instance the maximum height the closure cap (including the break-off parts) is in the range of 25 mm to 35 mm.